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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

PAR PHARMACEUTICAL, INC and ALKERMES PHARMA IRELAND LIMITED, Plaintiffs, v. BRECKENRIDGE PHARMACEUTICAL, INC., Defendant. C.A. No. __________________

COMPLAINT Plaintiffs Par Pharmaceutical, Inc. (Par) and Alkermes Pharma Ireland Limited (Alkermes) (collectively, Plaintiffs), for their Complaint against Defendant Breckenridge Pharmaceutical, Inc., allege as follows: NATURE OF THE ACTION 1. This is a civil action for infringement of United States Patent Nos. 6,592,903 (the

903 patent) and 7,101,576 (the 576 patent) pursuant to the Patent Laws of the United States, 35 U.S.C. 1, et seq. PARTIES 2. Plaintiff Par is a corporation organized under the laws of Delaware, with its

principal place of business at 300 Tice Boulevard, Woodcliff Lake, New Jersey. 3. Plaintiff Alkermes is an Irish corporation having a principal place of business at

Monksland, Athlone, Co. Westmeath, Ireland.


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Upon information and belief, Defendant is an entity organized under the laws of

Florida, with its principal place of business at 1141 S. Rogers Circle, Boca Raton, Florida. JURISDICTION 5. This Court has subject matter jurisdiction over this action under 28 U.S.C.

1331, 1338(a), 2201, and 2202, and 35 U.S.C. 271(e)(2). 6. Upon information and belief, Defendant is in the business of making and selling

generic pharmaceutical products, which it distributes, markets, and/or sells in Delaware, and throughout the United States. 7. Upon information and belief, Defendant has previously submitted to the

jurisdiction of the United States District Court for the District of Delaware, for example, in C.A. Nos. 11-1070-GMS and 12-810-SLR. 8. This Court has personal jurisdiction over Defendant by virtue of, inter alia,

Defendants continuous and systematic contacts with corporate entities within this judicial district, its previous submission to the jurisdiction of this judicial district, and its marketing and sales activities in this judicial district, including, but not limited to the substantial, continuous and systematic distribution, marketing and/or sales of generic pharmaceutical products to residents of this judicial district. VENUE 9. 1400(b). PATENTS-IN-SUIT 10. Plaintiff Alkermes is the lawful owner of the 903 patent. Venue is proper in this judicial district pursuant to 28 U.S.C. 1391 and

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The 903 patent, entitled Nanoparticulate Dispersions Comprising a Synergistic

Combination of a Polymeric Surface Stabilizer and Dioctyl Sodium Sulfosuccinate, duly and legally issued on July 15, 2003, naming Niels P. Ryde and Stephen B. Ruddy as inventors. A copy of the 903 patent is attached as Exhibit A. 12. 13. Plaintiff Alkermes is the lawful owner of the 576 patent. The 576 patent, entitled Nanoparticulate Megestrol Formulations, duly and

legally issued on September 5, 2006, naming Douglas Hovey, John Pruitt, and Tuula Ryde as inventors. A copy of the 576 patent is attached as Exhibit B. MEGACE ES 14. Plaintiff Par is the holder of New Drug Application (NDA) No. 21-778 for

Megace ES (megestrol acetate) oral suspension, 125 mg/mL, and is an exclusive licensee of the 576 and 903 patents with respect to Megace ES in the United States. 15. On July 5, 2005, the FDA approved NDA No. 21-778 for the manufacture,

marketing, and sale of Megace ES (megestrol acetate) oral suspension for the treatment of appetite loss, severe malnutrition, or unexplained, significant weight loss in AIDS patients. Plaintiff Par has sold Megace ES under NDA No. 21-778 since its approval. 16. The 903 and 576 patents are listed in the FDAs Approved Drug Products with

Therapeutic Equivalence Evaluations (the Orange Book) as covering Pars product Megace ES. DEFENDANTS ANDA 17. Upon information and belief, Defendant submitted ANDA No. 20-4688 to the

FDA under 35 U.S.C. 355(j), seeking approval to engage in commercial manufacture, use,

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and/or sale of megestrol acetate oral suspension, 125 mg/mL, (Defendants Generic Product) before expiration of the 903 and 576 patents. 18. Upon information and belief, ANDA No. 20-4688 refers to and relies upon

Plaintiff Pars NDA for Megace ES and purports to contain data showing bioequivalence of Defendants Generic Product with Megace ES. 19. Plaintiffs received from Defendant a letter dated May 16, 2013 (the Notification

Letter), stating that ANDA No. 20-4688 contains a certification pursuant to 21 U.S.C. 355(j)(2)(A)(vii)(IV) (a Paragraph IV certification) alleging that the 903 and 576 patents are invalid, unenforceable, and/or will not be infringed by the manufacture, use, or sale of Defendants Generic Product. 20. Letter. COUNT ONE (Infringement of the 576 Patent under 35 U.S.C. 271(e)(2)) 21. 22. Plaintiffs reallege paragraphs 1-20 above as if fully set forth herein. Defendants submission of ANDA No. 20-4688 to the FDA with a Paragraph IV Plaintiffs commenced this action within 45 days of receiving the Notification

certification regarding the 576 patent, seeking approval to engage in commercial manufacture, use, and/or sale of Defendants Generic Product before the expiration of the 576 patent, constitutes infringement of the 576 patent under 35 U.S.C. 271(e)(2)(A). COUNT TWO (Declaratory Judgment of Infringement of the 576 Patent under 35 U.S.C. 271(a)-(c)) 23. Plaintiffs reallege paragraphs 1-20 above as if fully set forth herein.

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24.

Upon information and belief, Defendant intends, soon after the FDA has approved

its ANDA No. 20-4688, to begin the commercial manufacture, use, offer to sell, or sale within the United States, and/or importation into the United States, of Defendants Generic Product. 25. Upon information and belief, Defendant has made, and will continue to make,

substantial preparation in the United States to manufacture, use, offer to sell, or sell within the United States, and/or import into the United States, Defendants Generic Product before expiration of the 576 patent. 26. Upon information and belief, Defendant has made, and will continue to make,

substantial preparation in the United States to actively induce or contribute to the manufacture, use, offer to sell, or sale within the United States, and/or importation into the United States, of Defendants Generic Product before expiration of the 576 patent. 27. Defendants actions, including without limitation the filing of ANDA No. 20-

4688, exhibit a refusal to change the course of its action despite Plaintiffs patent rights. 28. Upon information and belief, the commercial manufacture, use, offer to sell, or

sale within the United States, and/or importation into the United States, of Defendants Generic Product before expiration of the 576 patent, and the active inducement of and/or contribution to any of those activities, will constitute infringement, inducement of infringement and/or contributory infringement of the 576 patent. 29. Plaintiffs are entitled to a declaratory judgment that future commercial

manufacture, use, offer to sell, or sale within the United States, and/or importation into the United States, of Defendants Generic Product, or the inducement of and/or contribution to the commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States, of Defendants Generic Product before expiration of the 576 patent by

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Defendant or its agents, will constitute infringement, inducement of infringement and/or contributory infringement of the 576 patent. COUNT THREE (Infringement of the 903 Patent under 35 U.S.C. 271(e)(2)) 30. 31. Plaintiffs reallege paragraphs 1-20 above as if fully set forth herein. Defendants submission of ANDA No. 20-4688 to the FDA with a Paragraph IV

certification regarding the 903 patent, seeking approval to engage in commercial manufacture, use, and/or sale of Defendants Generic Product before the expiration of the 903 patent, constitutes infringement of the 903 patent under 35 U.S.C. 271(e)(2)(A). COUNT FOUR (Declaratory Judgment of Infringement of the 903 Patent under 35 U.S.C. 271(a)-(c)) 32. 33. Plaintiffs reallege paragraphs 1-20 above as if fully set forth herein. Upon information and belief, Defendant intends, soon after the FDA has approved

its ANDA No. 20-4688, to begin the commercial manufacture, use, offer to sell, or sale within the United States, and/or importation into the United States, of Defendants Generic Product. 34. Upon information and belief, Defendant has made, and will continue to make,

substantial preparation in the United States to manufacture, use, offer to sell, or sell within the United States, and/or import into the United States, Defendants Generic Product before expiration of the 903 patent. 35. Upon information and belief, Defendant has made, and will continue to make,

substantial preparation in the United States to actively induce or contribute to the manufacture, use, offer to sell, or sale within the United States, and/or importation into the United States, of Defendants Generic Product before expiration of the 903 patent.

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36.

Defendants actions, including without limitation the filing of ANDA No. 20-

4688, exhibit a refusal to change the course of its action despite Plaintiffs patent rights. 37. Upon information and belief, the commercial manufacture, use, offer to sell, or

sale within the United States, and/or importation into the United States, of Defendants Generic Product before expiration of the 903 patent, and the active inducement of and/or contribution to any of those activities, will constitute infringement, inducement of infringement and/or contributory infringement of the 903 patent. 38. Plaintiffs are entitled to a declaratory judgment that future commercial

manufacture, use, offer to sell, or sale within the United States, and/or importation into the United States, of Defendants Generic Product, or the inducement of and/or contribution to the commercial manufacture, use, offer for sale, or sale within the United States, and/or importation into the United States, of Defendants Generic Product before expiration of the 903 patent by Defendant or its agents, will constitute infringement, inducement of infringement and/or contributory infringement of the 903 patent. INJUNCTIVE RELIEF 39. Plaintiffs will be substantially and irreparably damaged and harmed by

Defendants infringing activities unless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at law. EXCEPTIONAL CASE 40. Defendant has at all relevant times been aware of the 576 and 903 patents, and

has had no good faith basis for its infringement of that patent. This is an exceptional case under 35 U.S.C. 285.

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PRAYER FOR RELIEF WHEREFORE, Plaintiffs respectfully request that this Court: A. Enter a judgment that Defendant has infringed the 576 patent under 35 U.S.C.

271(e)(2)(A) by submitting ANDA No. 20-4688 to the FDA, seeking approval to engage in commercial manufacture, use, offer to sell or sale of Defendants Generic Product before expiration of the 576 patent; B. Enter a declaration under 28 U.S.C. 2201 that Defendant would infringe the

576 patent under one or more of 35 U.S.C. 271(a)-(c) by its manufacture, use, offer to sell or sale within the United States, or importation into the United States, of Defendants Generic Product before expiration of the 576 patent; C. Enter a judgment that Defendant has infringed the 903 patent under 35 U.S.C.

271(e)(2)(A) by submitting ANDA No. 20-4688 to the FDA, seeking approval to engage in commercial manufacture, use, offer to sell or sale of Defendants Generic Product before expiration of the 903 patent; D. Enter a declaration under 28 U.S.C. 2201 that Defendant would infringe the

903 patent under one or more of 35 U.S.C. 271(a)-(c) by its manufacture, use, offer to sell or sale within the United States, or importation into the United States, of Defendants Generic Product before expiration of the 903 patent; E. Enter an order under 35 U.S.C. 271(e)(4)(A) that the earliest effective approval

date of ANDA No. 20-4688, if any, shall be no earlier than the date of expiration of each patentin-suit Defendant is found to infringe, including any extensions; F. Enter an injunction under 35 U.S.C. 271(e)(4)(b) and 283 permanently

enjoining Defendant, its officers, agents, servants, employees, licensees, representatives, and

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attorneys, and all other persons acting or attempting to act in concert or participation with them or on their behalf, from engaging in commercial manufacture, use, offer to sell, or sale within the United States, or importation into the United States, of Defendants Generic Product before the expiration of each patent-in-suit Defendant is found to infringe, including any extensions; G. Grant Plaintiffs compensatory damages in an amount to be determined at trial

including both pre-judgment and post-judgment interest if Defendant commercially manufactures, uses, offers to sell, or sells in the United States, or imports into the United States, Defendants Generic Product before the expiration of each patent-in-suit Defendant is found to infringe, including any extensions; H. Declare that Defendants activities have made this an exceptional case under 35

U.S.C. 285 and grant Plaintiffs their attorneys fees; and I. proper. Award Plaintiffs any further and additional relief as this Court may deem just and

Of Counsel: Daniel G. Brown LATHAM & WATKINS LLP 885 Third Avenue New York, New York 10022 Telephone: (212) 906-1271

YOUNG CONAWAY STARGATT & TAYLOR LLP /s/ James L. Higgins Karen L. Pascale (#2903) James L. Higgins (#5021) The Brandywine Building, 17th Floor 1000 West Street Wilmington, Delaware 19801 (302) 571-6600 kpascale@ycst.com jhiggins@ycst.com Attorneys for Plaintiff Par Pharmaceutical, Inc.

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MORRIS, NICHOLS, ARSHT & TUNNELL LLP /s/ Maryellen Noreika Jack B. Blumenfeld (#1014) Maryellen Noreika (#3208) 1201 North Market Street, 18th Floor P.O. Box 1347 Wilmington, DE 19899-1347 (302) 658-9200 jblumenfeld@mnat.com mnoreika@mnat.com Dated: June 21, 2013 Attorneys for Plaintiff Alkermes Pharma Ireland Limited

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